Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)
This study is currently recruiting participants.
Verified May 2013 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Collaborators:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Roche Pharma AG
Mairie de Paris
Biomerieux
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT01790633
First received: February 7, 2013
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).
Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.
The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.
| Condition | Intervention |
|---|---|
|
HIV Hepatitis B Hepatitis C Carcinoma, Hepatocellular AIDS |
Other: ELISA Other: Rapid Test |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests As a Tool for Screening and Access to Care Among At-Risk Populations |
Resource links provided by NLM:
Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
Primary Outcome Measures:
- Accessibility of testing results [ Time Frame: Evaluated once, up to 4 months after testing ] [ Designated as safety issue: No ]The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.
Secondary Outcome Measures:
- Access to care [ Time Frame: Evaluated once, up to 4 months after testing ] [ Designated as safety issue: No ]The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.
Other Outcome Measures:
- Proportion participating [ Time Frame: At testing ] [ Designated as safety issue: No ]The number of individuals accepting to participate in the study divided by the total number of individuals proposed.
- Proportion accepting to test [ Time Frame: At testing ] [ Designated as safety issue: No ]The number individuals accepting to test divided by the total number of individuals accepting to participate in the study.
- Proportion of rapid test failures [ Time Frame: At testing ] [ Designated as safety issue: No ]The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard testing with ELISA
HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
|
Other: ELISA
Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).
|
|
Experimental: Rapid testing
HBV, HCV, and HIV infection status determined by a rapid test
|
Other: Rapid Test
A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- At least 18 years of age
- Seeking care at the CASO MDM health care center
- Accept to be followed at Saint-Antoine Hospital in the event of a positive test.
Exclusion Criteria:
- Currently under physician's care for viral hepatitis (HBV/HCV-specific) or HIV
Already has been tested (must give any of the following as evidence):
- results from HBV and HCV and HIV tests dating at least 3 months back
- results from HCV and HIV tests dating at least 3 months back and HBV serology indicating that the participant is immunized against HBV.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790633
Contacts
| Contact: Julie Bottero, MD | 011-33-1-71-97-04-24 | julie.bottero@sat.aphp.fr |
| Contact: Hayette Rougier, BSc | 011-33-1-49-28-24-05 | hayette.rougier@sat.aphp.fr |
Locations
| France | |
| Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM) | Recruiting |
| Paris, France, 75011 | |
| Contact: Marie-Dominique Pauti 011-33-1-43-14-81-81 marie-dominique.pauti@medicinsdumonde.net | |
| Contact: Jean Nau 011-33-1-43-14-81-81 | |
| Principal Investigator: Marie-Dominique Pauti | |
Sponsors and Collaborators
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Roche Pharma AG
Mairie de Paris
Biomerieux
Investigators
| Principal Investigator: | Julie Bottero, MD | Hôpital Saint-Antoine |
More Information
Additional Information:
Publications:
| Responsible Party: | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
| ClinicalTrials.gov Identifier: | NCT01790633 History of Changes |
| Other Study ID Numbers: | IMEA 38B, 2012-A01681-42 |
| Study First Received: | February 7, 2013 |
| Last Updated: | May 7, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
|
rapid test screening ELISA hepatitis B virus |
hepatitis C virus human immunodeficiency virus access to care |
Additional relevant MeSH terms:
|
Carcinoma Hepatitis Hepatitis A Hepatitis B Hepatitis C Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013